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Maintenance of Multivitamin Supplements After Sleeve Gastrectomy

H

Hospital General Universitario Elche

Status and phase

Completed
Phase 3

Conditions

Iron Deficiency Anemia

Treatments

Drug: Multicentrum® (Pfizer, Spain) 12 months
Drug: Multicentrum® (Pfizer, Spain) 3 months

Study type

Interventional

Funder types

Other

Identifiers

NCT02620137
HURJC15-15

Details and patient eligibility

About

A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.

Full description

A prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. Patients were randomized into 2 groups: those patients receiving the multivitamin supplement (Multicentrum, Pfizer, 1 tablet/day) during 3 months (Group 1), and those receiving the supplement during 12 months (Group 2). Laboratory data were recorded: vitamins (D, B12 and folic acid) and oligoelements (calcium, iron, phosphorus, magnesium and zinc) at 3, 6 and 12 months after surgery.

Enrollment

80 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients undergoing laparoscopic sleeve gastrectomy
  • BMI >40 Kg/m2
  • BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity

Exclusion criteria

  • documented gastroesophageal reflux
  • patients with uncontrolled psychiatric disorders
  • active infections or malignancies
  • any other concomitant pathology considered as a contraindication for bariatric surgery.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Multicentrum® 3 months
Experimental group
Description:
Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 3 months
Treatment:
Drug: Multicentrum® (Pfizer, Spain) 3 months
Multicentrum® 12 months
Active Comparator group
Description:
Patients maintaining the multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) during 12 months
Treatment:
Drug: Multicentrum® (Pfizer, Spain) 12 months

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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